Cleared Traditional

K880168 - INCSTAR'S BIRCH ALLERGEN DISC

K880168 is the FDA 510(k) clearance for INCSTAR'S BIRCH ALLERGEN DISC by Incstar Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K880168 · Incstar Corp. · Immunology device
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May 1988
Decision
117d
Days
Class 2
Risk

K880168 is an FDA 510(k) clearance for the INCSTAR'S BIRCH ALLERGEN DISC. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on May 11, 1988 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Incstar Corp. devices

Submission Details

510(k) Number K880168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1988
Decision Date May 11, 1988
Days to Decision 117 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 104d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DHB System, Test, Radioallergosorbent (rast) Immunological

All 199
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K880168.
PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA
K880899 · Pharmacia, Inc. · May 1988
MARSH ELDER ALLERGEN DISC
K874540 · Incstar Corp. · May 1988
WALNUT ALLERGEN DISC
K874883 · Incstar Corp. · May 1988
INCSTAR'S PIGWEED ALLERGEN DISC
K880221 · Incstar Corp. · May 1988
GOLDENROD ALLERGEN DISC
K875163 · Incstar Corp. · Apr 1988
ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM
K875244 · Diagnostic Products Corp. · Apr 1988